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IntroductionPalbociclib is a widely used treatment for advanced breast cancer in older adults. However, the existing evidence regarding its safety and tolerability in this age group is inconsistent and limited to retrospective subgroup or pooled analyses.Materials and methodsWe conducted a prospective single-arm multicenter phase 2 study to evaluate the safety and tolerability of palbociclib in participants aged 70 years or older with advanced hormone receptor-positive breast cancer. Participants were given palbociclib in combination with their physician's choice of endocrine therapy (letrozole or fulvestrant). The primary endpoint was the incidence of grade 3+ adverse events (AEs) by six months. Secondary endpoints included AE-related dose delays, dose reductions, early discontinuations, and hospitalizations. Additionally, we compared these endpoints by age groups (70-74 and ≥ 75 years).ResultsOf the 90 participants (median age 74 years [70-87]) enrolled, 75.6% (95% confidence interval [CI], 65.4-84.0) had grade 3+ AEs by six months. The most frequent grade 3+ AEs were neutropenia (61%), fatigue (4%), and nausea (3%). Febrile neutropenia was uncommon (1.1%). Due to AEs, 36% had dose delays, 34% had dose reductions, 10% had early discontinuations, and 10% had hospitalizations. Compared to those aged 70-74 years, participants aged ≥75 years had higher rates of early discontinuations (5.9% vs 15.9%, a difference of 9.5% [95% CI 3.5%-22.5%]).DiscussionPalbociclib has an overall favorable safety profile in adults aged ≥70 with advanced breast cancer. However, adults ≥75 years had a trend toward higher rates of AE-related early discontinuations compared to those 70-74 years. Further research is needed to evaluate tolerability and improve the delivery of palbociclib in older adults.Clinicaltrialsgov:NCT03633331.

Objectives: To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL)., Setting: 23 U.S. community and minority oncology practice sites affiliated with the National Cancer Institute Community Oncology Research Program (NCORP)., Participants: 521 patients (≥18 years) with MM or CLL were consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%)., Interventions: Observational, prospective, protocol-based survey administered in 2019-2020., Primary and Secondary Outcome Measures: Financial difficulty was assessed using a single-item standard measure, the EORTC QLQC30: "Has your physical condition or medical treatment caused you financial difficulties in the past year?" and using an 'any-or-none' composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association between financial difficulty, diagnosis, and socioeconomic and treatment characteristics., Results: 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM versus CLL (adjusted odds ratio [aOR], 0.34; 95% CI, 0.13-0.84; P =.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37-4.66; P =.003), being non-White (aOR, 2.21; 95% CI, 1.04-4.72; P =.04), and having a high school education or below (aOR, 0.36; 95% CI, 0.21-0.64; P =.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41-0.94; P =.03)., Conclusions: U.S. patients with blood cancer report financial difficulty, especially those with low socio-economic status. Evidence-based and targeted interventions are needed., Competing Interests: Competing Interest Statement: Conti reports research support from the National Science Foundation, the National Cancer Institute, the National Institute on Drug Abuse, the Veterans Administration, the Leukemia and Lymphoma Society, the Sloan Foundation and Arnold Ventures and consulting fees from Greylock McKinnon Associates unrelated to this manuscript. All other authors declare no conflicts of interest to disclose.